PARIS, France -- BIOTRONIK, one of the leading manufacturers of cardiovascular medical technology, has announced the market release of Orsiro, the industry's first hybrid Drug-Eluting Stent (DES) combining an active BIOlute coating and a passive proBIO coating. The release comes after a succession of studies demonstrating Orsiro's safety and efficiency in the treatment of discrete de-novo stenotic lesions and in-stent restenotic lesions.

Two high profile studies, BIOFLOW-II and BIOFLOW-III, showed Orsiro performing as best in class. BIOFLOW-II was a prospective, international, multi-center, randomized trial evaluating the safety and efficacy of Orsiro compared with Xience Prime. The BIOFLOW-II and -III subgroup analyses released this year demonstrated the top performance of Orsiro in the treatment of patients with small vessel disease and complex B2/C lesions, respectively. The results of the much larger investigator-initiated BIOSCIENCE trial, which compared Orsiro with Xience Prime in a larger patient population more reflective of routine clinical practice, have further confirmed the ultra-thin Orsiro as best in class. The BIOSCIENCE results were published in the prestigious general medical journal The Lancet.

"We have been tracking Orsiro closely as its use widens globally, waiting for it to come to us," said Prof. Didier Carrié, Interventional Cardiologist, University Hospital of Toulouse, France, who was among the first to implant one of the new stents. "It is of great benefit to my practice that I am now able to offer treatment with Orsiro to patients here in France. Thanks to its bioabsorbable polymer coating, it is the best chance we have at minimizing adverse events."

Based on the PRO-Kinetic Energy platform, Orsiro offers exceptional flexibility without compromising scaffolding or fatigue resistance, while a thinner 60 µm strut design ensures minimal vessel injury. The stent will be offered in up to 40 mm lengths, making it one of the longest drug-eluting stents on the market. Its design allows for stent expansion without affecting the performance of the polymer coating, ensuring improved patient outcome when treating coronary artery stenosis, even in patients with particularly long lesions.

"We are happy to announce that the Orsiro hybrid DES, one of three stent systems in the BIOTRONIK Masterpieces portfolio along with the PRO-Kinetic Energy bare metal stent and the PK Papyrus covered stent, will now be available to yet another patient population that needs it," commented Dr. Alexander Uhl, Vice President of Marketing, BIOTRONIK Vascular Intervention. "Physicians rely on top performing tools for each and every procedure. We see the launch of Orsiro in France as a crucial step towards giving an even greater number of physicians worldwide the chance to work with a tool that we consider a Masterpiece."

About Orsiro

The Orsiro Hybrid Drug-Eluting Stent (DES), launched in 2011, features the latest development in BIOTRONIK stent technology – a unique hybrid solution that combines passive and active components. proBIO passive coating encapsulates the stent and minimizes interaction between the metal stent and the surrounding tissue. BIOlute active coating contains a highly biocompatible polymer that delivers a limus drug via a bioabsorbable matrix. This hybrid coating system is layered on top of the high performance PRO-Kinetic Energy stent platform, renowned for its advanced thin-strut stent design and exceptional deliverability.

About BIOTRONIK

One of the world's leading manufacturers of cardio- and endovascular medical devices, BIOTRONIK is headquartered in Berlin, Germany, and represented in over 100 countries by its global workforce of more than 5,800 employees. Several million patients have received BIOTRONIK implants designed to save and improve the quality of their lives, or have been treated with BIOTRONIK coronary and peripheral vascular intervention products. Since its development of the first German pacemaker in 1963, BIOTRONIK has engineered many innovations, including BIOTRONIK Home Monitoring®; the world's first 4 F-compatible 200mm peripheral stent; Orsiro, the industry's first hybrid drug-eluting stent; and the world's first implantable cardioverter-defibrillators and heart failure therapy devices with ProMRI® technology.